Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03772457

Collaborator

Bayer (Industry), Taizhou Hospital (Other), Zhuji People's hospital (Other), Shaoxing People's Hospital (Other), Jinhua Central Hospital (Other), HaiyanPeople's hospital (Other), Wenzhou Central Hospital (Other), The Central Hospital of Lishui City (Other), Dongyang People's Hospital (Other), Rui'an People's hospital (Other)

400

Enrollment

Location

47.4

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Stroke Intracranial Hemorrhages Anticoagulant Matrix Metalloproteinases	Drug: Rivaroxaban

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

Actual Study Start Date :

Jan 18, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment [14 days after enrolling]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female, age≥18;
Were newly diagnosed asischemic stroke/TIA concomitant NVAF;
Prescribedand accept Rivaroxaban;
Sign thewritten informed consent.

Exclusion Criteria:

Renal impairment (CrCl<15 ml/min) or severe hepatic impairment.
Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).
Stroke or TIA caused by large artery atherosclerosis
Planned major surgery or invasive intervention
Active internal bleeding
Malignancy or other serious medical conditions with a life expectancy <6 months
Allergery to Rivaroxaban
Pregnancy or breast-feeding